ABSTRACT NUMBER: ESOC2026OT107 RECOMBINANT FACTOR VIIA (RFVIIA) FOR ACUTE HEMORRHAGIC STROKE ADMINISTERED AT EARLIEST TIME (FASTEST) TRIAL

Abstract Background and aims The FASTEST trial was designed to evaluate whether ultra-early administration of recombinant activated factor VII (rFVIIa) in an enriched subgroup, can improve outcomes in spontaneous intracerebral hemorrhage (ICH). Methods To determine whether rFVIIa administered within 120 minutes of symptom onset slows growth at 24 hours and improves functional outcomes at 180 days as measured by the modified Rankin Scale in patients with ICH. Results FASTEST is a phase III, international, randomized, adaptive, double-blind, placebo-controlled trial comparing rFVIIa (80 μg/kg; maximum dose 10 mg) plus best standard therapy versus placebo plus best standard therapy. In FASTEST Part 1, eligible participants were aged 18–80 years, had spontaneous ICH with a volume ≥2 cc and <60 cc, a Glasgow Coma Scale score ≥8, limited intraventricular hemorrhage, and could be treated within 120 minutes of stroke onset. Imaging included baseline and 24-hour non-contrast CT scans of the head and CT angiography (CTA) when done as standard of care. A neuroradiologist centrally assessed volume of ICH and intraventricular hemorrhage (IVH), and the presence of spot sign on CTA. Conclusions FASTEST Part 1 was stopped for futility overall in January 2025 after enrollment of 626 participants. Based upon data from FASTEST Part 1, FASTEST Part 2 began in May 2025 with the same entry criteria as Part 1, but patients must have a spot sign on CTA if treated within 120 minutes or be treated within 90 minutes. Conflict of interest